Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Adults

Acute Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Women and Men

The aim of this study is to investigate the postprandial metabolic responses to plant-based protein ingredients of different degrees of processing (pea protein concentrate, isolate, and extrudate) and in comparison to whey protein in healthy adults. Therefore, young healthy subjects consume 4 test meals with 25 g of protein from pea protein concentrate, pea protein isolate, pea protein extrudate or whey protein in a randomized order. In a postprandial period of 6 hours, parameters of protein and glucose metabolism (i.a. plasma amino acids), gastric emptying and hunger/satiety are analysed. It is assumed that the plasma amino acid profile after plant protein ingestion differs depending on processing level of the protein ingredients and in comparison to whey protein.

Study Overview

• Status: Active, not recruiting
• Conditions: Plasma Amino Acid Appearance and Disappearance; Postprandial Metabolic Events
• Intervention / Treatment: Other: Pea protein concentrate; Other: Pea protein isolate; Other: Pea protein extrudate; Other: Whey protein

Detailed Description

In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 25 g of protein from plant protein ingredients (pea protein concentrate, isolate, or extrudate) or whey protein together with 1 g paracetamol, which is used as a marker for gastric emptying.

During a postprandial period of 6 hours parameters of protein metabolism (e.g. amino acids in plasma and urine), glucose metabolism (plasma glucose, serum insulin) and gastric emptying rate (based on plasma paracetamol) are analysed. Furthermore, subjective hunger/satiety and acceptance of the meals are assed using visual analogue scales. Each intervention arm will be separated by a washout period of at least 7 days.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53115
    • University of Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• non-smoking
• metabolically healthy
• normal weight (BMI: 18,5 - 24,9 kg/m2)
• written informed consent

Exclusion Criteria:

• pregnancy, lactation
• hypo- or hypertension
• underweight or overweight/obesity
• food intolerances and allergies (especially milk protein, pea, celery)
• malabsorption syndromes
• gastrointestinal diseases
• thyroid diseases
• diabetes mellitus type 1 and type 2
• impaired kidney or liver function
• anaemia
• blood coagulation disorders
• irregular menstrual cycle
• endometriosis, severe menstrual problems
• hormonal contraception
• regular use of medications (especially habitual use of paracetamol or medications that may interact with paracetamol)
• hypersensitivity to paracetamol
• body weight below 50 kg
• alcohol abuse
• glucose-6-phosphate dehydrogenase deficiency
• Gilbert's syndrome
• vegan diet
• eating disorders (especially anorexia nervosa, bulimia nervosa)
• smoking
• participation in another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pea concentrate; Participants randomized to receive a soup containing 25 g of protein from pea protein concentrate	Other: Pea protein concentrate; Ingestion of a soup containing 25 g of protein from pea protein concentrate
Experimental: Pea isolate; Participants randomized to receive a soup containing 25 g of protein from pea protein isolate	Other: Pea protein isolate; Ingestion of a soup containing 25 g of protein from pea protein isolate
Experimental: Pea extrudate; Participants randomized to receive a soup containing 25 g of protein from pea protein extrudate	Other: Pea protein extrudate; Ingestion of a soup containing 25 g of protein from pea protein extrudate
Active Comparator: Whey; Participants randomized to receive a soup containing 25 g of protein from whey protein	Other: Whey protein; Ingestion of a soup containing 25 g of protein from whey protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amino acid profile in blood	Analysis of amino acid profile in plasma (nmol/ml)	Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters of protein metabolism in blood I	Analysis of urea (mg/dL and mol/L) in blood	Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Parameters of protein metabolism in blood II	Analysis of nitrogen (mg/dL) in blood	Postprandial period of 5 hours (Time points: fasting (0) and 60, 120, 180, 240 and 300 minutes)
Parameters of glucose metabolism in blood I	Analysis of glucose (mg/dL and mmol/L) in blood	Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Parameters of glucose metabolism in blood II	Analysis of insulin (nmol/L and pmol/L) in blood	Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Gastric emptying rate	Analysis of gastric emptying rate based on paracetamol kinetics in blood (µg/mL)	Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Hunger/satiety and acceptance of the meals	Assessment of subjective hunger/satiety and acceptance of the meals by validated visual analogue scale questionnaires (e.g., 0 = not hungry at all, 10 = very hungry)	Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)
Amino acid profile in urine	Analysis of amino acids in urine (nmol/mL)	Postprandial period of 5 hours
Uric acid in blood	Analysis of uric acid (mg/dL and mmol/L) in blood	Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)

Collaborators and Investigators

• Sponsor: University of Bonn
• Collaborators: German Federal Ministry of Education and Research; University of Bonn, Department of Nutrition and Food Sciences, Food Sciences
• Investigators: Principal Investigator: Sarah Egert, Prof PhD, Germany University of Bonn

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): May 20, 2024
• Study Completion (Estimated): May 20, 2024

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Postprandial metabolic events
• Other Study ID Numbers: AlProPlant-HS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No